Σχόλια 0

Το κείμενο του εγγράφου

Inter-Departmental Group onModern BiotechnologyReportOCTOBER 2000BAILE AÂTHA CLIATHARNA FHOILSIUÂAG OIFIG AN tSOLAÂTHAIRLe ceannach dõÂreach oÂnOIFIG DHIÂOLTA FOILSEACHAÂN RIALTAIS,TEACH SUN ALLIANCE,SRAÂID THEACH LAIGHEAN,BAILE AÂTHA CLIATH 2,noÂtrõÂd an bpost oÂFOILSEACHAÂIN RIALTAIS,AN RANNOÂG POST-TRAÂCHTA,4 - 5 BOÂTHAR FHEARCHAIR,BAILE AÂTHA CLIATH 2,(Teil:01 - 6476834/35/36/37;Fax:01 - 4752760)noÂtrõÂaon dõÂoltoÂir leabhar.ÐÐÐÐÐÐDUBLINPUBLISHED BY THE STATIONERY OFFICETo be purchased directly from theGOVERNMENT PUBLICATIONS SALE OFFICE,SUN ALLIANCE HOUSE,MOLESWORTH STREET,DUBLIN 2,or by mail order fromGOVERNMENT PUBLICATIONS,POSTAL TRADE SECTION,4 - 5 HARCOURT ROAD,DUBLIN 2,(Tel:01 - 6476834/35/36/37;Fax:01 - 4752760)or through any bookseller.ÐÐÐÐÐÐ(Pn.9124) £10.00\12.70ContentsPagesIntroduction 6Executive Summary 8Chapter 1 Biotechnology:Science and Industry 35I The Biotechnology Revolution 35II Medical and Environmental Applications ofGenetic Engineering 38III Initial Applications of Genetic Engineering inFood Production 42IV The Commercialization of GM Crops andFoods 45V Future Applications of GM Technology 51VI The Emergence of the Modern BiotechnologyIndustry 56Chapter 2 GMOs,Food Safety and theEnvironment 65I GMOs,Food Safety and Human Health 65II GMOs and the Environment 73III Biotechnology:The Balance of Risks andBenefits 89Chapter 3 The Public Disquiet about GeneticModification 93I The Growth of Public Disquiet about GeneticModification 93II The Causes of Public Disquiet about GeneticModification 94III Ethical Objections to Genetic Modification 105IV Corporate Dominance of AgriculturalBiotechnology 1103PagesChapter 4 The Regulation of GMOs 119I The Development of a Regulatory Frameworkfor GMOs 119II Main Features of the EU RegulatoryFramework 122III The Contained Use of Genetically ModifiedMicro-Organisms 125IV The Deliberate Release of GeneticallyModified Organisms 128V Food Safety 136VI Labelling of GM Products 140VII GM Medicines 142VIII GM Animal Feedingstuffs,Seed,and Pesticides 145IX The Regulation of GMOs in the United Statesand Other Countries 149X National Consultation on GMOs and theEnvironment 154Chapter 5 Conclusions and Recommendations 157I Conclusions 157II Strengthening the Regulatory Framework atEU Level 165III Strengthening the Regulatory and PolicyFrameworks at National Level 171IV Improving Public Communication andConsultation 182Annex A The Growth of Genetic Knowledge 195Annex B Chronology of the Development ofGenetic Engineering 203Annex C Research by Dr.Arpad Pusztai onGenetically Modified Potatoes 2124PagesAnnex D Summary of the Report of the ChairingPanel to the National ConsultationDebate on GMOs and the Environment 216Annex E Policy Statement of the Minister for theEnvironment and Local Government onGMOs and the Environment,October1999 224Annex F Membership of the Inter-DepartmentalGroup 2315IntroductionIn March 1999,the Government noted the range of concerns raisedby genetic modification and approved the establishment of an Inter-Departmental Group on Modern Biotechnology to report with a co-ordinated overall Government position as soon as possible.The Groupwas to be chaired by the Department of Enterprise,Trade and Employ-ment (at Assistant Secretary level) and to comprise senior officials ofthe Departments of Health and Children;Agriculture,Food and RuralDevelopment;Environment and Local Government;and a representa-tive of the Food Safety Authority of Ireland.Representatives ofEnterprise Ireland and ForfaÂs were co-opted onto the Group to assist itin its work,while an official of the Department of Education andScience joined the Group after October 1999.The membership of theGroup is given at Annex F.The policy statement on Genetically Modified Organisms and theEnvironment issued by the Minister for the Environment and LocalGovernment in October 1999,with the approval of the Government,expressly requested the Group to consider the following issues:· information dissemination on genetic engineering,particularly inrelation to information being made available by the various Stateagencies and also the overall co-ordination of that information;· the case for a national biotechnology ethical committee to overseedevelopments in modern biotechnology;· the teaching of science,particularly at secondary level,havingregard to potential economic growth in biotechnology.· future policy and administrative co-ordination on geneticengineering;6· the possible establishment of an independent body at EU level(funded by a levy on the biotechnology industry) to validatescientific data and to undertake independent research on geneticengineering;· a possible research role for the EU Food and Veterinary Office.The Group examined a wide range of biotechnology-related issues anddevelopments,including the review of a sizeable body of literature.Wedecided at an early stage of our work that we would not consider theissue of cloning.Though related to genetic engineering,cloning raisesa host of different and highly complex issues which merit in-depthexamination in their own right.For similar reasons,other issues relatedto human genetic engineering,as well as those raised by the geneticengineering of animals,are not dealt with in this report.Peter Buckley,Department of Enterprise,Trade and Employment,served as the secretary to the Group.Bill Cox drafted the report withthe assistance of inputs from members.We thank both for their work.The Group was also assisted in its deliberations by a number of Govern-ment departments and agencies.We are grateful to them for their helpand co-operation.7Executive SummaryChapter 1 ÐBiotechnology:Science andIndustryI The Biotechnology RevolutionAdvances in the understanding and manipulation of genetic structureover the past quarter century have made it possible to introduce,delete,or enhance particular traits in an organism either by inserting genesfrom another organism or by otherwise altering its genetic make-up.Within a short space of time,these advances in genetics have broughtabout major changes in fields as varied as pharmaceuticals,medical diag-nostics,agriculture,food production,and forensic science.Medical Applications of Genetic EngineeringThe first commercial applications of the new techniques of geneticengineering occurred in the pharmaceutical field.In all,it is estimatedthat several hundred million people worldwide use the ninety or sobiotechnology drugs and vaccines now on the market.Biotechnologyhas also become a key tool of medical diagnostics Ð that is tests forchanges or foreign material in the body that are characteristic of particu-lar diseases.Gene therapy Ðthe insertion of functioning genes to sup-plement or replace defective genes,or treat the effects of acquired dis-eases Ðis widely seen as having the potential to have a major effect onmedical practice in the future.Biotechnology and the EnvironmentThough the practical applications of environmental biotechnology havegenerally lagged behind those in medical and plant biotechnology,manyscientists believe that biotechnology can play an important part indeveloping sustainable solutions to the problems of air,soil,and waterpollution,and waste treatment and reduction.On the opposite side,con-cerns have been raised about the potential impact of genetically modifiedorganisms (GMOs) on the environment,particularly biological diversity.8Initial Applications of Genetic Engineering in Food and DrinkProductionMuch of the hard cheese now produced is made using approvedenzymes from genetically modified microbes.Cheese made in this waydoes not contain GMOs as the modified enzymes do not remain in thefinished product.A number of genetically engineered strains of yeastsused in baking and brewing have also been developed.To date,noneof these have been used by food or drink manufacturers.MilkIncreases in the levels of Bovine somatotropin (BST),a hormone nat-urally produced by cattle,can raise milk yields significantly.In the1980s,genetically engineered varieties of the hormone known asrecombinant BST [rBST] were developed.RBST has been approvedfor use in the United States since 1993 and is now applied to over 30per cent of American dairy cattle.Because of concerns about the poss-ible impact of rBST on human and animal health,a moratorium on itsuse was imposed in the European Union in 1991 and renewed in 1999.II The Commercialization of GM Crops and FoodsBetween 1986 and 1997,some 25,000 field trials of 60 crops Ðprinci-pally soybeans,maize,cotton,rapeseed,tomatoes and sugar beet Ðwere undertaken in 45 countries.The first genetically modified fruit orvegetable to be cleared for sale to consumers Ð a tomato modified toremain firm longer than conventional varieties Ð received approvalfrom the U.S.Food and Drug Administration in 1994.The cultivationof GMcrops in the United States has since grown rapidly and,in 1999,transgenic varieties accounted for almost half of U.S.cotton andsoybean acreage,and over one-third of maize acreage.Though theEuropean Union has granted authorization for a number of GM cropvarieties,the acreage under cultivation in member states is minimal.Nofruit or vegetable containing`live'GMOs is on sale to consumers inthe EU.9III Future Applications of GM TechnologyThe scope and pace of innovation in biotechnology over the past quar-ter-century has been profound,but many believe it will be dwarfed bythat in the decades ahead.The decipherment of the human genome islikely to be the key to the future understanding of disease and develop-ment of medicine and healthcare.In plant biotechnology,the simul-taneous introduction of large numbers of genes in order to modify com-plex traits will become a possibility.Future developments in the area ofGMfoods may include fats and oils containing substantially lower levelsof saturated fat;grains,fruits and vegetables with`built- in'food sup-plements and medicines;and fruits and vegetables which can remainfresh for longer and reduce wastage.IV The Emergence of the Modern BiotechnologyIndustryThe first`new biotechnology'company was established in 1976;therewere around two hundred such companies by 1984 and 1,000 by 1988.As the number of small firms grew,large pharmaceutical and agribus-iness companies also assumed an increasingly prominent role.From themid-1990s,these companies sought to become`life sciences'concernsspanning pharmaceutical,agricultural,and food biotechnology.As aresult of consumer opposition to GM crops and foods,this strategy hasrecently suffered a number of reverses as large companies have soughtto decouple their agribusiness from healthcare activities for fear that theformer had become a liability.American firms continue to dominate the global biotechnology industrywith aggregate revenues some six times those of their Europeancounterparts.In Ireland,the biotechnology industry is still in its infancy.The number of start-ups has grown in recent years,however,while therecent decision of American Home Products Corporation to establish amajor facility here to develop and produce genetically engineered drugsis a critical addition to our biotechnology base.The Government10decision of March 2000 to establish a £560 million Technology Fore-sight Fund over seven years to fund world class research in selectedniche areas of biotechnology and information and communication tech-nology should contribute to the creation of a vibrant biotechnologysector in this country in the years ahead.Chapter 2 ÐGMOs,Food Safety and theEnvironmentI GMOs,Food Safety and Human HealthThere is broad agreement among most scientists,among independentfood regulatory bodies in this country and other EU and OECD mem-ber states,and among international bodies such as the World HealthOrganization and the UN Food and Agricultural Organization that theGM food products currently on the market are as safe as their conven-tional counterparts.There have been no reports of adverse effects fromthe consumption of GM foods,particularly in the US where they havebeen freely available since 1995 and have been consumed by tens ofmillions of people.This does not warrant complacency or justify theconclusion that all future GM food will necessarily be free of adverseeffects.Major considerations in the assessment of GM foods include toxicity,allergenicity,and antibiotic resistance.ToxicityToxins are poisonous substances produced by living organisms;plants,for example,produce them as protection against insects and other pests.In the assessment of GM foods,toxicity is one of the key traits investi-gated by biotechnology companies and regulatory bodies.In theunlikely event that a GM food plant was developed which expressedtoxins harmful to humans,it would not receive regulatory approval.11AllergenicityAllergens are substances which provoke an allergic reaction on exposureby consumption or contact.Concerns have been expressed that theintroduction of new genes into plants might unintentionally introduceproteins capable of causing allergic reactions.The main safeguard againstthis occurring lies in the detailed analysis,assessment and evaluation towhich these products are subject before they can be put on the market.In view of the current gaps in our knowledge of allergies,however,theeffectiveness of the procedures used to identify possible allergens in GMfoods should be subject to regular monitoring and review.Antibiotic-Resistant Marker GenesWhen a new gene is inserted into an organism,researchers will oftenalso insert a`marker'gene to help them ascertain whether the trans-ferred gene has been successfully incorporated.Genes for resistance toa range of antibiotics have been used as selectable markers for sometime,and their use has given rise to concerns that these genes could betransferred to bacteria present in the human stomach,thereby makingthem resistant to commonly prescribed antibiotics.Though the possi-bility cannot be ruled out,the Food Safety Authority of Ireland andother regulatory bodies have indicated that the risk is extremely low.Selectable markers based on antibiotic resistant genes should neverthe-less be avoided in our view and alternative marker systems used.II GMOs and the EnvironmentThe second main area of concern raised by genetic modification is thatof the possible effects of GMOs on the environment.The principalissues raised to date include the effects of herbicide-tolerant crops onherbicide use,the possible hazards resulting from the transfer of genesfrom GM crops to weeds and non-GM crops,the effects of insect-resistant crops on non-target insects,and the possible emergence ofenhanced resistance to insect-resistant crops.A prudent approach must12be taken in view of the relative lack of research data on large-scalereleases of GM crops,such as oilseed rape,in European conditions.Herbicide-Tolerant CropsTo date,tolerance to herbicides has been the characteristic most com-monly engineered into transgenic crops.It has been claimed that,because herbicide-tolerant crops permit farmers to apply herbicidewithout fear of crop damage,their introduction will lead to a rise inherbicide use.Statistical data on the effects of herbicide-tolerant cropson pesticide use now becoming available from the United StatesDepartment of Agriculture and other sources,however,suggest that,while there are significant crop and regional variations,the adoption ofthese crops has been associated with either no change,or a reduction,in herbicide applications.Gene Escape and Gene TransferConcerns have also been expressed that genes from herbicide-tolerantplants could be transferred to weeds,thereby creating herbicide-resistantweeds (what are sometimes termed`superweeds'),or that seeds shedduring the harvesting of herbicide tolerant crops could themselves growas weeds in future crops.Though cross-pollination of GM and non-GM crops and plants is possible,it can only occur where a GM cropplant has sexually compatible relatives in the area in which it is grown.GM maize and potatoes have no wild or weed relatives in Europe,though oilseed rape and sugar beet do.Gene transfer is also unlikelyamong inbreeding crop species such as rice and soya,and among cropssuch as cereals which are predominantly self-pollinating.There are also significant obstacles against plants modified for herbicidetolerance or other traits themselves becoming weeds.In general,cropsdo not have the kind of characteristics necessary for survival as weeds.With limited exceptions,crosses between cultivated crop species andwild relatives will not generally prove competitive in the wild.Wherethey do,they,like the GM crops from which they derived,would beresistant only to certain herbicides and could be treated with others.13The likelihood of gene transfer to non-GM crops depends,like that towild plants,on the biology of the crop species and its location.As thecommercial cultivation of GM crops compatible for breeding purposeswith crops grown organically draws closer,effective procedures,suchas prescribed isolation distances,will be needed to prevent any impactwhich might affect the viability of organic farming.The need to pro-ceed with caution in this area has been underlined by the disclosure inMay 2000 of the presence of GM material in seed of a conventionalGMoilseed rape variety imported fromCanada and sown commerciallyon farms in a number of EU countries.Though the GM presence wasat a relatively low level and posed no threat to human health,the inci-dent aroused understandable concern.The Department of Agriculture,Food and Rural Development,in consultation with the EnvironmentalProtection Agency,is to establish an appropriate monitoring and controlsystem to ensure that contaminated seed is not imported in the future.The European Commission is bringing forward legislation to addressthe problem,and this country should strongly support legislative pro-posals that will offer an effective framework for the detection and testingof GM material in seed imports.Large-scale trials are currently underway in a number of countries tocompare the impact of conventional farming and biotechnology onbiodiversity.A programme of research designed with Irish conditionsin mind is recommended in chapter 5.Insect-Resistant GM CropsGenes expressing toxins fromthe soil bacteriumBacillus thuringiensis (Bt)Ða natural toxin highly effective against particular groups of insect butnot harmful to other organisms Ð have been engineered into maize,cotton,and potatoes.As these crops produce the toxin within the planttissue,they offer farmers a means of pest control that is easier to useand less dependent on weather conditions than conventional insecticidesprays.Data from the United States Department of Agriculture suggestthat,in most cases,the cultivation of crops modified for insect resistance14has led to significant reductions in insecticide use Ða positive outcomefrom an environmental standpoint.To date,the majority of field andlaboratory studies to date have not shown evidence of adverse effects ofinsect-resistant crops on non-target insects.Concerns have been expressed that insects might evolve resistance toBt crops more rapidly than to conventional insecticides because thetoxins incorporated into the crops are continuously switched on asopposed to being intermittently sprayed.The principal counter-measureagainst the threat of enhanced resistance consists of the provision of`refuges',that is areas of non-GM crops,which can support pest popu-lations that are not resistant to Bt toxins.While such provisions help toaddress the problem,there is a need for continued careful monitoringof the risk of enhanced resistance to Bt crops.III Biotechnology:The Balance of Risks andBenefitsThe risks associated with genetic modification should neither be minim-ized or magnified but should be assessed and managed in accordancewith scientific principles and procedures.They should also be evaluatedin the light of the risks posed by conventional farming (includingorganic farming) and food production methods.Many of the hazardsattributed to genetic modification have been established trends in con-temporary societies long before the introduction of GM crops andfoods.Genetic engineering has already provided considerable benefits in thepharmaceutical area,and offers major potential benefits in the medical,agricultural,and environmental fields.It will also be a critical source ofeconomic growth and innovation in the future.These benefits Ð andthe economic and other costs of missing out on them Ðmust be con-sidered alongside the possible risks.On the evidence to date,effectiveprovision for pre-release testing,ongoing research,and post-release15monitoring can ensure that the benefits of modern biotechnology aremaximized and the risks minimized without compromising on the pro-tection of human health and the environment.This does not warrantcomplacency about future applications of genetic engineering.GMcrops and foods must continue to be rigorously assessed on a case-by-case basis.Chapter 3 ÐThe Public Disquiet aboutGenetic ModificationI The Growth of Public DisquietA number of factors have contributed to the emergence of public con-cern about GM crops and foods in this and other European countries,among them the problems encountered in dealing with complex scien-tific issues in public debate and the mass media.The following factorshave also played a part in the growth of public unease about geneticmodification:· Increased public concern about food safety resulting fromthe BSEoutbreak and other cases of food contamination and food-bornedisease;· A decline in public confidence in regulatory bodies and scientistsin the wake of the BSE outbreak;· Mistrust of the large corporations that have pioneered GMcrops;· The campaign against GM crops and foods waged by environ-mental groups.II Ethical and Other Objections to GeneticEngineeringIn considering the ethical issues raised by modern biotechnology,it isuseful to distinguish between ethical objections to the very process of16genetic modification and objections which focus on the ways in whichit is applied and exploited.The evidence suggests that fundamentalopposition to the entire process of genetic modification is not supportedby the majority of the population in Ireland and the rest of Europe.As well as those with deep-rooted objections to genetic engineering,there are others,who,while not expressing complete opposition,feelnevertheless that it is in some way unnatural or distasteful.The strengthof such sentiments generally increases in line with the species distancebetween the organisms involved in gene transfers.Others would con-tend that,as gene transfers are possible only because all life forms havea common origin and shared features,they are in another sense quite`natural'.Unease about genetic modification may also be a result of the ways inwhich it is depicted.Some accounts of the subject tend to present adistorted picture of the nature and extent of the transformations broughtabout by genetic modification.Most applications of genetic engineeringin agricultural biotechnology to date have involved the transfer of one,two,or three genes into plants which typically have in the region of50,000 genes.We have found no reasons to conclude that the current applications ofgenetic engineering are unacceptable on ethical grounds.Future,morefar-reaching applications of GM technology may raise more difficultmoral issues.Opposition to genetic modification on ethical groundsshould be respected and,as far as possible,be taken into account bypolicymakers and regulators.In particular,persons with ethical,religious,or other objections to genetic engineering should,by means ofclear and consistent labelling provisions,be able to identify geneticallymodified foods and to avoid their consumption.17III Corporate Dominance of AgriculturalBiotechnologySome of the opposition to genetic engineering reflects disquiet at theaims and activities of the large biotechnology companies responsible forits commercialization.There are also concerns that genetic engineeringwill do nothing to help,and may do much to harm,smallholder agri-culture and the environment in poorer countries.Though we have no wish to defend large biotechnology corporations,we are concerned that disapproval of their practices has unduly colouredthe entire debate about modern biotechnology.Companies in otherindustries pursue market share and protect their intellectual propertywith the same vigour as biotechnology corporations,but are seldomsubject to the same level of criticism.Where they are so criticized,thedistinction between the possibly undesirable nature of some corporatepractices and the beneficial character of the technology is readilyappreciated.Developments in intellectual property law governing biotechnology arecentral to some of the concerns expressed about the commercial prac-tices of biotechnology companies.Fears have been expressed in particu-lar that biotechnology firms will patent gene sequences without havingfirst identified a utility for them,thus effectively monopolizingsequences without understanding their function.Sequence data fromthe human and other genome projects should in our view be readilyaccessible to scientists in free databases.We note that the EU Directiveon the Legal Protection of Biotechnological Inventions stipulates thatthe industrial application of a gene sequence must be disclosed in thepatent application Ðin other words that a mere DNA sequence with-out indication of a function is not a patentable invention.18Chapter 4 Ð The Regulation of GMOs inIreland and the EUI Main Features of the EU Regulatory FrameworkThere is now an extensive body of regulations governing geneticallymodified organisms in this country which derives from EU Directivesthat have been transposed into domestic legislation here,and from EUregulations that are directly applicable and binding in Member States.This body of EUlegislation comprises a comprehensive regulatory codewhich covers all of the main stages of the innovation cycle Ðfrom thecontained use of genetically modified micro-organisms (GMMs) in thelaboratory for research purposes,to their deliberate release into theenvironment in field trials,to the placing on the market of productscontaining or consisting of GMOs.The main areas covered by the EU regulatory framework are:· the contained use of genetically modified micro-organisms;· the deliberate release of genetically modified micro-organisms to theenvironment (for both field trial and general marketing purposes);· the marketing within the EU of novel foods and novel foodingredients,including foods or food ingredients containing orderived from GMOs;· the labelling of GM products;· the licensing of medical products,including those derived from,containing,or consisting of GMOs;· quality standards and other marketing requirements for animalfeedstuffs,including feed additives;· the marketing of new varieties of agricultural crop species,includ-ing GM seed;and· the use of pesticides.19The key features of the approach to the regulation of GMOs in EUlegislation are as follows:· an emphasis on the protection of human health and theenvironment· a requirement for prior approval by a competent national auth-ority for the use,release,or marketing of GMOs· provision for communication,consultation and joint decision-making among Member States.The EU regulatory code governing GMOs is set to be supplementedand strengthened in the period ahead as existing Regulations and Direc-tives are amended and new Regulations and Directives enacted.II The Regulation of GMOs in the United Statesand Other CountriesRecent years have seen a gradual relaxation of the regulatory regimegoverning GM crops in the United States.Nineteen varieties of sevenGMcrops are now no longer subject to regulation.The approach takenby the US Food and Drug Administration to the regulation of GMfoods and food ingredients also differs significantly from that followedin Europe.In 1992,the FDA ruled that foods derived from new plantvarieties produced by genetic modification should,unless special cir-cumstances were applicable,be regulated no differently than foods pro-duced by conventional means.The FDA similarly does not require foodproducts to be expressly labelled simply because they contain or consistof GMOs.It recently announced its intention,however,to developvoluntary guidelines for the labelling of GM foods.World Trade and GMOsAmerican producers maintain that the more restrictive regulatoryregime governing GMOs in force in Europe may be in breach of WorldTrade Organisation rules.High-level discussions between the EU and20the US have failed to resolve these differences.Issues of global tradeand market access have also arisen in the context of discussions on aBiosafety Protocol under the UN Convention on Biological Diversity.A summit in Montreal in January 2000 finalized an agreement,to beknown as the Cartagena Protocol on Biosafety,for protecting the envir-onment fromthe risks posed by trans-boundary shipments of geneticallymodified organisms.The Protocol will permit countries to rejectimports of GM crops if they have grounds to believe that these pose asafety risk.It provides also that shipments of GM products should bearlabels stating that these may contain GMOs.III National Consultation on GMOs and theEnvironmentIn August 1998,the Minister for the Environment and Local Govern-ment issued a national consultation paper on GMOs and the Envir-onment``in order to stimulate public debate in advance of reviewingnational environmental policy in this area.The Minister then invitedrespondents to the consultation paper to participate in a two-part debateheld in May and June 1999 and managed by an independent chairingpanel.The Chairing Panel's report,which was presented to the Ministeron 28 July 1999,concluded that the focus of national environmentalpolicy on the deliberate release of GMOs should be positive in reco-gnizing the potential economic benefits of genetic engineering,butshould also reflect a fundamental national commitment to safety andenvironmental sustainability based on scientific risk assessment and man-agement.In October 1999,the Minister for the Environment and LocalGovernment issued a policy statement which confirmed Governmentacceptance of the conclusions of the independent chairing panel andgave a commitment to act on its recommendations.21Chapter Five ÐConclusions andRecommendationsI ConclusionsThe formulation of public policy on biotechnology involves attemptingto strike an appropriate balance between benefits and risks,long andshort-term needs,and the interests of different groups such as producersand consumers.We have sought to take four main considerations intoaccount:· an appreciation of the long-term strategic importance ofbiotechnology· an acceptance of the need for a precautionary approach,guidedby scientific principles and procedures,to the development andapplications of biotechnology.· a commitment to an independent,well-resourced regulatorysystem operating on the basis of the best available scientificexpertise and advice.· an acknowledgement of the need for more effective mechanismsof public information,communication,and consultation on mod-ern biotechnology.The Long-Term Strategic Importance of BiotechnologyThere is virtual unanimity among leading scientists and industrialiststhroughout the world that biotechnology will be at the forefront ofadvances in knowledge and innovation in the coming decades.Thereis widespread agreement likewise that,subject to public concerns beingaddressed,biotechnology has the potential to deliver major benefits toindividuals and societies in areas such as healthcare,agriculture,andenvironmental remediation.On the basis of the best knowledge avail-able to us,therefore,the development of world class competence inbiotechnology on a basis compatible with the protection of human22health and the environment is essential,not optional,for Ireland andEurope.The Need for A Precautionary ApproachPromotion of biotechnology must be balanced by precaution.Theextent to which a precautionary approach to genetic engineering hasbeen followed in this country and the European Union is not alwaysappreciated.Five years after the large-scale cultivation of GMcrops gotunderway in the United States,there have been no commercial plant-ings of these crops in this country,while the acreage of GM cropsremains negligible in the European Union as a whole.This precaution-ary approach is reflected in precautionary legislation.The EU Directive90/220/EEC on the Deliberate Release of GMOs was among the firstpieces of international legislation expressly to incorporate the pre-cautionary principle.The Need for an Independent Well-Resourced RegulatorySystemIn the European Union,public confidence in the regulatory frameworkgoverning genetic modification has been dented by the BSE outbreakand other factors.If biotechnology is to be promoted as a key strategicsector,it is imperative that the regulatory authorities possess the fullrange of resources and expertise required to oversee it effectively.It isvital also that regulatory bodies are,and are seen to be,independent ofthe industrial interests that stand to gain fromthe authorization of prod-ucts by regulatory authorities.Public Communication and ConsultationMore effective means must be found of informing the public about,and involving it in,developments and decisions concerning biotechnol-ogy.This is more a matter of conveying an appreciation of the econ-omic,social,environmental and ethical implications of the science andits applications than of providing detailed technical information.This isnot an easy task,nor is it likely to be accomplished in the short term,but it should now be seen as a priority.23II Strengthening the Regulatory and PolicyFramework at EU LevelThe regulatory system governing genetic modification in this and otherEU member states has been put in place gradually over the past decade.Inevitably,experience,the example of other countries,and the evol-ution of the technology have disclosed gaps in the existing frameworkthat must be dealt with,and revealed new needs that must be addressed.The period ahead will see concerted action on a number of fronts bythe EU to reform and strengthen the legal and institutional bases of thepresent regulatory system.Ireland must play its full part in this processof policy formulation and decision-making.We recommend thatIreland's general stance at EU level and in international forumsshould be positive but precautionary.It should acknowledge thepotential benefits of genetic engineering,while maintaining a funda-mental commitment to safety and environmental sustainability based onscientific risk assessment and management.New EU LegislationThe cornerstone of EU legislation on genetic modification ÐDirective90/220/EEC on the deliberate release of genetically modified organismsto the environment Ð is currently in the process of amendment tostrengthen its safety and transparency provisions in a range of areas.Westrongly support the central thrust of the proposed amendments,manyof which address issues and concerns considered by us.The next legislative proposal on genetic modification due to arise atEU level is expected to deal with novel animal feed,in particular feed-ingstuffs containing or derived from GMOs.We recommend thatthis country should support the introduction of EUlegislation toregulate novel and GManimal feed.This legislation should containprovisions requiring the evaluation of the safety,efficacy,and controlof such feedingstuffs;it should also include specific labelling provisions.24The European Commission's White Paper on Food Safety indicatedthat the legal provisions governing novel foods,in particular those con-taining or derived fromgenetically modified organisms,should be tight-ened and streamlined.The labelling provisions governing novel foodsare also to be completed and harmonized.We recommend that thiscountry should strongly support proposals for the amendmentof the Novel Foods Regulation that will improve the effective-ness of the procedures governing the authorization and labellingof GM foods.New European Food AuthorityThe White Paper on Food Safety also proposed the establishment of anindependent European Food Authority with particular responsibilitiesfor both risk assessment and risk communication on food safety issues.In our view,a well structured,properly resourced European food safetyagency can make a significant contribution to the creation of greaterconfidence among consumers in the safety of the food they eat.Muchwill depend on the precise,role,structure,and resources of the pro-posed Authority.Care will need to be taken to ensure that there is noorganizational duplication,confusion,or conflict with national foodsafety agencies.European Union Scientific BodyThe policy statement on GMOs and the environment issued by theMinister for the Environment and Local Government in October 1999requested the Inter-Departmental Group to examine the possible estab-lishment of an independent EU body,perhaps funded by industry levy,to validate scientific data and undertake independent research on geneticengineering.The Group was also asked to consider a possible researchrole in this context for the European Union's Food and VeterinaryOffice which is based in this country.Though much of the detail concerning the proposed European FoodAuthority remains to be worked out and discussed,it would appear25that,in the food safety area for which it will have responsibility,itsremit will be close in many ways to that of the EU scientific bodysuggested by the Minister for the Environment and Local Government.We propose to refer our conclusions and recommendations to theEuropean Commission in order to make the case for a comparablecentre of independent scientific expertise in the environmental field.The White Paper on Food Safety also emphasized the importance ofhaving effective control systems in place to ensure that Communityrules are implemented and enforced consistently by Member States.Itis clear that this key function of the Food and Veterinary Office willtake precedence over any possible research role for the foreseeablefuture.III Strengthening the Regulatory and PolicyFramework at National LevelField Trials for GM CropsA comprehensive well-managed trial process is essential to ensure thatthe risks posed by GMcrops can be scientifically evaluated.We recom-mend that trials of GM crops should continue in this countrysubject to compliance with EU legislation and with the controlsand conditions laid down by the Environmental ProtectionAgency.If a GM agricultural plant variety is approved by the EPA for releaseinto the environment,the Department of Agriculture,Food and RuralDevelopment may be required under national legislation to test seed ofsuch a variety for marketing and seed certification purposes.Such testsare conducted by means of field and laboratory trials.We consider thatmore detailed provisions for the management of field trials of GMcropsare desirable in this context.We recommend that the Departmentof Agriculture,Food and Rural Development should,in consul-tation with the EPA,draw up detailed protocols governing themanagement of such field trials for agricultural GMcrop species26under the marketing authorization procedures for the seed ofsuch crops.These protocols would cover matters such as the locationof trials,and the distances between field trials and related neighbouringcrops.Where GMcrops have received marketing approval under the Deliber-ate Release Directive,we think that,in keeping with the precautionaryprinciple,there is merit in a phased approach to their cultivation tocommercial scale.We recommend that the Department of Agri-culture,Food and Rural Development,in co-operation withother bodies as appropriate,should devise a programme ofmanaged development of GMcrops.This would entail limiting thearea of transgenic crops in the first year,while monitoring and auditingthem for safety.If no adverse effects on the environment are found,plantings could,under strict supervision,be progressively increased insubsequent years to full commercial cultivation.The Ethical Dimension of Genetic EngineeringWe have found no reasons to conclude that the current applicationsof genetic engineering are unacceptable on ethical grounds.We fullyacknowledge that others may take a different view and that their beliefsmust be respected and,where possible,their concerns addressed.It is now time in our view to establish a forum in this country toconsider the ethical issues raised by biotechnology in an informed,dis-passionate,and independent way.A key role for any such forum willbe to clarify the ethical issues concerned,formulate them in moralterms,and communicate them to decision-makers,scientists and thegeneral public.We recommend that the Royal Irish Academy beinvited to consider how it might set up and maintain a nationalbiotechnology ethics committee.Though the Government wouldbe entitled to refer questions to such a body for consideration,theproposed committee should be fully independent in its operations.27Strengthening the Regulatory Authorities in IrelandResourcesThe regulation of complex,science-based products and processes,suchas those deriving from modern biotechnology,requires that regulatorybodies be adequately staffed and resourced.The Minister for the Envir-onment and Local Government is currently undertaking,in conjunctionwith the Environmental Protection Agency,a review of the Agency'sresources for its role in biotechnology regulation.A review of the FoodSafety Authority's resources is also underway in advance of its formalassumption of the role of assessment body and competent authorityfor this country for the purposes of the Novel Foods Regulation.TheDepartment of Agriculture,Food and Rural Development will similarlyhave to review the resources at its disposal in the light of its new andproposed responsibilities for regulating the marketing of geneticallymodified seed varieties,including protocols for GM field trials,and forproposed EU legislation on novel animal feed.The over-riding need is to ensure that individual regulatory bodies,andthe national regulatory system as a whole,have adequate access to thefull range of specialist competences.This will require that the rightbalance is achieved and maintained between the respective roles of full-time staff,external consultants,and academics serving on a voluntarybasis.Where this requires new approaches and arrangements,such assharing the services of specialist staff among agencies who would notindividually have sufficient work for them to justify full-time posts,theregulatory bodies should be prepared to show the necessary creativityand flexibility.We consider that the scope for getting the biotechnologyindustry to meet all or part of the cost of national regulatory arrange-ments for the industry should be examined.We recommend that,asa first step,the reviews of the resources of the EPA and the FSAIshould look at the fees charged by those bodies for assessment,including trials and tests.28Composition of Advisory Committees of Regulatory BodiesThe Minister for the Environment and Local Government has indicatedhis intention to amend the 1994 GMO regulations in order to providefor direct representation of consumer interests on the EnvironmentalProtection Agency's GMO Advisory Committee.The Food SafetyAuthority of Ireland has a consumer representative on its board and isin the process of establishing a twenty-four member consultative councilin order to provide a more effective channel of communication forconsumer views and concerns.We welcome the enhanced provisionfor consumer representation being made by both bodies.It is vital in our view that the independence and integrity of the regulat-ory system is upheld.We recommend that members of the GMOadvisory committees attached to the Environmental ProtectionAgency and the Food Safety Authority of Ireland should declareany personal or business interest which might,or might reason-ably be seen,to influence their judgement on matters comingbefore the committee.Such registers should be available to thepublic.Plans to establish registers of this kind are already under con-sideration,or are in the process of implementation,by the regulatorybodies in this country.Research on Biotechnology and GMOsWe consider it essential that,before GM crops are put on the market,and for a period thereafter as appropriate,adequate research data areavailable to the regulatory authorities here to enable them to assess theirenvironmental impact in Irish conditions.An exclusive reliance on stud-ies carried out by biotechnology companies is not desirable and will notfoster public confidence.We recommend that independent genericresearch (i.e.not limited to any particular product) be conduc-ted in this country into all aspects of GMOs,including humanhealth and safety,animal feed and live crops,and the effects ofGMOs on the Irish environment having regard to our distinctiveclimatic and geological conditions.29In response to a request from the Minister for the Environment andLocal Government,the Environmental Protection Agency is currentlyengaged in identifying and formulating a programme of research onissues related to the deliberate release of GMOs to the environment.Similar programmes of research are needed on the food safety,animalhealth,and agronomic aspects of genetic modification.We recom-mend that the Food Safety Authority of Ireland,the Food SafetyPromotion Board,the Department of Agriculture,Food andRural Development and Teagasc,and the Marine Institute beasked to identify research programmes on issues related to gen-etic modification which are outside the scope of the proposedresearch by the EPA on the environmental impact of GMOs.Itwill be necessary to ensure that there is effective co-ordination acrossthese research programmes.Teagasc,the Agriculture and Food Development Authority,has a cen-tral role to play in devising and undertaking research into GM cropsand foods which takes adequate account of Irish needs and conditions.The Minister for Agriculture,Food and Rural Development recentlyannounced a £25 million fund to re-orientate the R&D programmeadministered by Teagasc in order,among other things,to monitor,evaluate,and where appropriate,harness developments in biotechnol-ogy.We recommend that,in addition to undertaking indepen-dent evaluations of the trials carried out by companies,Teagascshould have the capacity to undertake its own programme ofefficacy trials of GM crops.Future Policy Co-OrdinationFormulating,implementing,and monitoring policy on biotechnologyrequires a high level of consultation among a sizeable number ofGovernment departments and agencies.We recommend that theInter-Departmental Group should be placed on a permanentfooting in order to ensure that the Government has an inte-grated view of the full range of relevant issues and devel-opments.We recommend that the Group should in future30include representatives of the Food Safety Promotion Board;the Environmental Protection Agency;Teagasc;and theDepartment of Arts,Heritage,Gaeltacht and the Islands;as wellas of Enterprise Ireland and ForfaÂs.ForfaÂs should henceforth pro-vide the secretariat to the Group.IV Improving Public Communication andConsultationInformation and CommunicationThere is a clear need for the provision of better and more accessibleinformation to the general public on biotechnology and genetic engin-eering.The Minister for the Environment and Local Government hasasked the Environmental Protection Agency to identify a programmeof information dissemination on environmental aspects of geneticengineering.We recommend that the Food Safety PromotionBoard and the Food Safety Authority of Ireland,as appropriate,should provide information to the public,on both an ongoingbasis and in response to specific developments of public interestor concern,on the food safety aspects of genetic modifi-cation.We suggest that both the EPA and the FSAI should interprettheir responsibilities as extending not only to assessing the safety ofGMOs,but also to informing the public in situations where those assess-ments suggest that no hazard exists.The regulatory bodies in this country can further assist public infor-mation and awareness by making the maximum information available,subject to the constraints of commercial confidentiality,on applicationsfor the deliberate release or marketing of GMOs.In recent cases,theEPA has,with very limited excisions of commercially sensitive infor-mation,made publicly available the full dossier on applications for delib-erate release authorizations.We recommend that,in the interestsof transparency and public awareness,the fullest possible levelof information about applications for release or marketing31approvals for GMOs should be made available as a matter ofstandard practice by all of the relevant regulatory bodies.New ways of informing the public about biotechnology,its existingand potential future benefits,and the possible risks to health and theenvironment,should be devised and deployed.We recommend thatall feasible,cost-effective means of communication should beconsidered for this purpose,including television and radio docu-mentaries,information videos,and the internet.As well as thewebsites provided by the individual regulatory bodies,werecommend that there should be a central Government websitewhich would provide a broad range of relevant,up-to-dateinformation on biotechnology in a manner accessible to thegeneral public.ForfaÂs is the most suitable body in our view to set upand maintain such a website.The policy statement issued by the Minister for the Environment andLocal Government in October 1999 stated that,while responsibilityfor information dissemination in relation to specific areas of geneticengineering should rest with the individual State agencies concerned,the issue of the overall co-ordination and adequacy of the informationprovided should be examined further by the Inter-Departmental Group.As no other body is in a position to take an overviewof the field,we recommend that the issue of co-ordination across agencies inrelation to information and communication on biotechnologyshould formpart of the ongoing work programme of the Inter-Departmental Group.EducationThe large number of students taking Science at Junior Certificate leveland taking either Biology or Agricultural Science at Leaving Certificatelevel,together with the introduction of new syllabi in all three subjects,offer a good basis for improving the general level of public awarenessof biotechnology in the future.The universities,agencies such asBioResearch Ireland,and Irish biotechnology companies can play an32important supporting role by providing teaching resource packs throughthe Irish Science Teachers'Association,as well ideally as material forpractical activities.We recommend that a biotechnology website(such as BioResearch Ireland's BioZone site) should be providedon the Scoilnet web system for second-level students.There is a need also for broader changes to make science subjects moreattractive and relevant to second-level students in the longer term.Werecommend that:· The curricula of science subjects should in future bereviewed on a continuing basis to enhance their appeal tostudents,including to students not intending to pursuescientific careers.· School-based practical assessment should be implementedfor all science subjects,including Biology.· A General Science subject should be introduced at LeavingCertificate level which would aimto give students a broadappreciation of science and its economic,social,and ethi-cal implications.The MediaThe media are a key source of information on matters of current debateand controversy such as genetic engineering.To the extent that mediacoverage of the issue has been one-sided,this appears to have been duein large part to the fact that environmental groups opposed to geneticengineering have enjoyed greater credibility with the public.In seekingto respond to inaccurate media reports about genetic engineering,scien-tists have been handicapped by the fact that they need time to reviewclaims before responding to them.In many cases,however,the issue inquestion will have ceased to be of interest to the media before a con-sidered academic response can be prepared.We recommend that themedia should take due account of these constraints on scientistsin reporting on,and seeking reaction to,breaking news storiesabout genetic modification.33Public Consultation and ParticipationThe consultation process on``GMOs and the Environment''launchedby the Minister for the Environment and Local Government in August1998 was of considerable benefit in allowing issues and concerns to beraised and debated publicly.Other ways of promoting public consul-tation and involvement,such as discussion groups on the internet,debates involving different forms of lay and expert jury,and formalparticipative technology assessment exercises should be activelyexplored.We recommend that ForfaÂs should examine the use ofsuch mechanisms in other countries with a view to developingand piloting proposals for implementation in this country.Consumer Choice and LabellingIn the last analysis,the decision about whether or not to purchase GMfoods will rightly rest with individual consumers.We recognize thestrong public demand for the labelling of GM foods and support theneed for public choice to be facilitated by the clear,unambiguous label-ling of food products.The European Commission has indicated itsintention to introduce a Regulation on the labelling of GMO-freefoodstuffs which would give producers the possibility of using labellingclaims referring to the absence of genetic engineering techniques in theproduction of foodstuffs.Provided that it is legislated for andimplemented in a clear and workable manner,such a provision wouldfoster and facilitate consumer choice.Regulation (EC) 49/2000 which came into effect in April 2000 sets a1 per cent threshold for the adventitious,or accidental,presence ofmaterial derived fromGMsoya or maize in food ingredients.The intro-duction of such a provision makes it imperative that we establish facili-ties in this country with the analytical capabilities to detect GMmaterialin food.We recommend that the State Laboratory should be des-ignated as the national reference laboratory for GM-relatedanalysis and should be given adequate resources for the task.Itsremit should also cover the identification of GMmaterial in seed,crops,animal feed,and other products.34Chapter 1 ÐBiotechnology:Science and IndustryI The Biotechnology RevolutionBiotechnology can broadly be defined as the use of biological materialsand processes for human needs.1For the past 10,000 years,crop plantsand livestock have been bred for desired qualities;the fermentation offruits and grains to make wine,beer,and spirits is likewise an age-oldactivity.Over this long timescale,great benefits have come about as aresult of the selection and crossing of plants or animals with valued andcomplementary traits.Crops such as maize and wheat,for example,emerged over a period of several thousand years from the selection ofthe best seeds of the most favoured plants of various wild grass species.The cabbage,cauliflower,Brussels sprout,and broccoli are all selectedvariants of the same species,Brassica oleracea.The selective breeding ofthe wolf and the horse has resulted in more than 130 different dogbreeds and 100 different horse breeds.Over the past century,the increasingly systematic nature of breedingmethods,together with improvements in animal feed and the increaseduse of chemical inputs,have produced remarkable growths in agricul-tural yields.Average annual milk yields,for example,have risen fromaround 1,000 litres per cow in 1900 to 4,000 litres in 1990.2The so-called Green Revolution of the 1950s and 1960s boosted production ofwheat,rice and other staple crops by several hundred per cent by1The account of the development of biotechnology in this chapter and at annex A is based mainlyon the following sources:S.Aldridge.1996.The Thread of Life:The Story of Genes andGenetic Engineering (Cambridge:Cambridge University Press).W.Bains.1998.Biotechn-ology from A to Z (Oxford:Oxford University Press).R.Bud.1993.The Uses of Life:AHistory of Biotechnology (Cambridge:Cambridge University Press).S.Nottingham.1996.Eat your Genes:How Genetically Modified Food is Entering our Diet (London:ZedBooks).Nuffield Council on Bioethics.1999.Genetically Modified Crops:The Ethical andSocial Issues.Royal Commission on Environmental Pollution.13thReport.1989.TheRelease of Genetically Engineered Organisms to the Environment.(London:HMSO).R.Straughan,and M.Reiss.1996.Improving Nature?:The Science and Ethics of GeneticEngineering (Cambridge:Cambridge University Press).C.Tudge.1993.The Engineer inthe Garden (London:Jonathan Cape).The following websites were also consulted:www.bio.org;www.nal.usda.gov;www.ncbe.reading.ac.uk;www.agbiotechnet.com;www.biotech.iastate.edu/ed;and www.jic.bbsrc.ac.uk.2S.Nottingham.1996.Eat your Genes:How Genetically Modified Food is Entering ourDiet (London:Zed Books):28-33.35methods such as crossing varieties with short stalks and rigid stems inorder to create higher-yielding,more weather-resistant crops.3Though the techniques of traditional plant and animal breeding have beengreatly refined over time in these and other ways,they remained confinedto cross-breeding between individuals of the same,or closely related,spec-ies.Over the past quarter-century,breakthroughs in the understandingand manipulation of genetic structure have made it possible to vault thesespecies barriers and have greatly enlarged the scope for the deliberateengineering of desired genetic changes.Techniques of genetic engineeringnowmake it possible to introduce,delete,or enhance particular traits in anorganismeither by inserting genes fromanother organismor by otherwisealtering its genetic make-up.Genetically modified organisms are definedaccordingly in European Union legislation as those in which`the geneticmaterial has been altered in a way that does not occur naturally by matingor by natural recombination'.Within a short space of time,these advances in genetics have broughtabout major changes in fields as varied as pharmaceuticals,medical diag-nostics,agriculture,food production,and forensic science.The pro-found and pervasive nature of these changes Ðand the clear evidencethat they are as yet in their infancy Ðhave led to a widely held view,outlined in Box 1 overleaf,that a technological revolution is underwayin biotechnology comparable to those created by the replacement ofsteampower by electricity in the 19thcentury and the wave of informat-ics and telecommunications innovations of the 20thcentury.Our grow-ing knowledge of genetics has laid the foundation for this revolution.Annex A gives an account of the evolution of our knowledge of thegenetic composition of living things since the 19thcentury.It also out-lines the main processes and techniques involved in genetic modifi-cation.This chapter looks at the commercial applications of theadvances in genetics of the past quarter century and at the biotechnol-ogy industry to which they have given rise.As will be apparent,these3Gordon Conway.1999.The Doubly Green Revolution (London:Penguin Books):44-65.36applications are more long-standing and wide-ranging than the recentcontroversies over GM crops and foods might suggest.Box 1:Biotechnology:Potential and PredictionsModern biotechnology is one of the fields offering the greatest potential forinnovation and growth.The European Commission.4[Biotechnology] may well play as pivotal a role in social and industrial advance-ment over the next 10 to 20 years as did physics and chemistry in the post WorldWar II period.The US National Science and Technology Council.5I'm a big believer in information technology...but it's hard to argue that theemerging medical revolution,spearheaded by the biotechnology industry,is anyless important.Bill Gates,Microsoft.6The dominant science of the twenty-first century will be biology.Two branchesof biology in particular,genetics and neurophysiology,present us with an abun-dance of fundamental unsolved problems that new technological tools will enableus to attack.Freeman Dyson,Emeritus Professor of Physics,ColumbiaUniversity.7The biological sciences will be the most exciting science and technology for thenext few decades.Ben Rosen,Chairman,Compaq Computer Company.8There is a huge fear of genetic engineering,yet those who are close to sciencewould understand that this is the next big frontier to be crossed.There is a hugepotential for good,there is a huge opportunity.We must go forward on thatbasis rather than turning our backs on the science.The late Dr.Pat UptonT.D.9It is widely believed that biotechnology will be one of the most significant tech-nologies of the early decades of the 21stcentury...there is a huge opportunityfor Ireland to join in,to contribute to,and to benefit from,the next phase ofthe biotechnology revolution...no country with a strong food and pharmaceut-ical industry can afford to ignore the new biotechnology.10Health and LifeSciences Panel,Technology Foresight Ireland Task Force.4Commission of the European Communities.1993.White Paper on Growth,Competi-tiveness & Employment.5National Science and Technology Council.1995.Biotechnology for the 21stCentury:NewHorizons.6Genetic Engineering News,1 March 1997.7Imagined Worlds (Cambridge,Mass.:Harvard University Press,1997):86.8Caltech News,vol.32,no (2),1998.9Dail Debates,26 February 1998.10Report of the Health and Life Sciences Panel,Technology Foresight Task Force of theIrish Council for Science,Technology and Innovation.1999:10 & 13.37II Medical and Environmental Applications ofGenetic EngineeringMedicine and HealthcareThe first commercial applications of the new techniques of geneticengineering occurred in the pharmaceutical field.In 1978,Americanscientists isolated the segment of human DNA responsible for creatinginsulin and inserted it into an E.coli bacterium.11This enabled the bac-teria to create insulin as part of its normal biological processes,therebymaking possible the provision of an abundant supply of recombinanthuman insulin at a relatively low cost;prior to this advance,insulin wasobtained from the pancreases of pigs or cows.Recombinant humaninsulin was approved for use in the United States and other countriesin 1982.In 1980,US scientists succeeded in producing interferon by recombi-nant DNA techniques.12Interferon,a chemical produced by cells in thehuman body in response to viral attack,promotes production of a pro-tein that stimulates the immune system to combat the spread of infec-tion.It is produced by the body in such minute quantities,however,that blood from 90,000 donors is required to provide just one gram ofinterferon.The interferon thus obtained is only about 1 per cent pureand is also prohibitively expensive Ða single gramcost around $50,000to produce in the 1970s.The use of genetic engineering techniquespermitted the production of a cheap and plentiful supply of the protein.The first genetically-engineered interferon product received approval asa treatment for leukaemia in 1986.Other treatments fromthe interferonfamily have followed for cancers,AIDS,and other conditions,thoughnot all have realized the initial hopes placed in them.A genetically engineered treatment for growth hormone inadequacywas developed in 1985.This has eliminated the need to manufacture11R.Bud.1993.The Uses of Life:A History of Biotechnology (Cambridge:CambridgeUniversity Press):181.12Eric R.Grace.1997.Biotechnology Unzipped:Promises and Realities (Washington D.C.:Joseph Henry Press):78-79.38the product from pituitary glands taken from deceased adults and chil-dren.A genetically engineered hepatitis B vaccine followed in 1986.13Another important pharmaceutical product produced with the aid ofbiotechnology is Factor VIII,the blood clotting agent absent in haemo-philiacs.Almost all haemophiliacs who received factor VIII up to themid-1980s contracted AIDS or hepatitis from viral contaminants in theblood used to make it.The use of recombinant factor VIII eliminatesthe possibility of such contamination.Other genetically engineereddrugs include Erythropoietin which is used by people on kidney dialysisand reduces the need for blood transfusions,and Pulmozyme which iswidely used to treat lung congestion in cystic fibrosis sufferers.Table 1 below lists the principal new drugs that have been producedthrough the use of genetic engineering.In all,it is estimated that severalhundred million people worldwide use the ninety or so biotechnologydrugs and vaccines now on the market.14As some 350 biotechnologymedicines are currently in late-stage clinical trials,the importance ofthe technology for healthcare is set to grow further in the future.Biotechnology has also become a key tool of medical diagnostics Ðthat is,tests for changes or foreign materials in the body that are charac-teristic of particular diseases.There are now more than 600 diagnosticproducts on the market that are based on biotechnology,the main onesbeing immuno-assays and DNA-probe assays.15Gene therapy is a further key area in the medical application of biotech-nology.The first stage of such therapy Ð identifying genes associatedwith disease Ð is already well established.The next stages Ðthe suc-cessful insertion of functioning genes to supplement or replace defectivegenes,or to treat the effects of acquired diseases such as cancer Ð arecurrently the subject of extensive trials.These trials are attempting to13OECD.1996.`Biotechnology and the New Revolution in Health Care and Pharmaceuticals'.STI Review no.19.14Biotechnology Industry Organisation.18 January 2000.`Biotechnology Drug ApprovalsTop 90':www.bio.org.news.15European Biotech 1997:A New Economy.The Fourth Annual Ernst and Young Reporton the European Biotechnology Industry.39Table 1:Examples of approved and advanced biotechnology drugs/vaccinesApplication ProductAutoimmune diseasesMultiple sclerosis IFN- *Rheumatoid arthritis TNF- antibodyBlood deficienciesAnaemia ErythropoietinBlood substitute HaemoglobinChemo-induced haemophilia G-CSF Factor VIIICancerBone marrow transplant GM-CSFLeukaemia IFN- *T-cell lymphoma IL-2 fusion toxinMelanoma IL-2/melanoma vaccineRenal cancer IL-2/IFN- *Myocardial infarctiones TPAAngina/restenosis GP-llb/111a antibodyGenetic diseasesCystic fibrosis DnaseDiabetes Human insulinGaucher's disease GlucocerebrosidaseGrowth deficiency HGHHepatitis-B virus IFN-/subunit vaccine*HIV IFN-/IL-2*Papilloma virus IFN- *Bordatella pertussis Acellular vaccineInflammatory disordersAllergy IgE antibodyGraft-versus-host-disease tac antibodySeptic shock BPINervous system disordersAmyelotrophic lateral sclerosis IGF-1Trauma PEG-SODTissue damageWound healing TGF/PDGF*Interferon therapiesSource:OECD.1998.Economic Aspects of Biotechnologies Related toHuman Health:15.40refine the vectors used to insert the therapeutic DNA into cells.Methods of administration are also being examined as are dosage levelsand interactions with other drugs.Setbacks have been experienced insome areas of treatment,though more success has been recorded inothers,such as the treatment of children with immunodeficiency dis-eases.Though gene therapy treatments have the potential to have amajor effect on medical practice,it is likely to be another 10-20 yearsbefore they are in widespread use.Biotechnology and the EnvironmentDespite some advances,the practical applications of environmentalbiotechnology have generally lagged behind those in medical and plantbiotechnology.This is partly because of concerns about the release ofthe genetically-engineered microbes used in bioremediation into theenvironment;the deployment of such microbes outside sealed labora-tories is currently strictly controlled.Many scientists,as well as organiza-tions such as the OECD,believe nevertheless that biotechnology canplay an important part in developing sustainable solutions to the prob-lems of air,soil,and water pollution,waste treatment and reduction,and,in time perhaps,global climate change.On the opposite side,con-cerns have been raised about the potential impact of GMOs on theenvironment,particularly biological diversity.Among the main areas of research and development at present are thefollowing:16· bioremediation:cleaning up contaminated soil using biologicalprocesses;· the development of crops requiring fewer,or no,chemical inputs;· waste disposal:developing bacterial methods for disposing ofwaste,or at least disposing of the biodegradable part of it morerapidly;16OECD 1994.Biotechnology for a Cleaner Environment:Prevention,Detection,Remediation.41· the further development of biodegradable replacements for plas-tics and of biotechnological ways of making them;· soil amelioration:improving soil quality through manipulation ofmicroflora;· creating alternative energy sources such as biofuels and biogas.III Initial Applications of Genetic Engineering inFood ProductionCheeseThe first commercial application of the techniques of genetic modifi-cation in food production occurred in cheese-making.17Cheese-makingrequires the use of protease enzymes to curdle milk and turn it intosolid curds and liquid whey.The traditional source of these proteaseenzymes was chymosin,also known as rennin,the principal clottingagent present in rennet which has long been used in cheese-making.Rennet is derived from the stomach of a number of animals,mostcommonly calves;fungal sources of protease have also been developed.In 1981,scientists isolated the DNA encoding chymosin from calf cellsand inserted it in bacteria.Others followed their lead,including Irishlaboratories,with some using yeast cells rather than bacteria to clonethe chymosin.It should be noted that cheese produced with such chy-mosin is not itself a genetically modified organism or does not containsuch organisms,but is rather the product of a GMO.Neither the bac-teria producing the enzymes,nor the enzymes themselves,remain inthe finished product;these are used in very small quantities and breakdown as the cheese matures.Chymosin produced with the aid of gen-etic engineering has superior purity and reliability to calf chymosin;itis also preferred by some vegetarians.In 1988,chymosin was the first enzyme from a genetically-modifiedsource to obtain official authorization for use in food production.Three17University of Reading.1998.`Chymosin for cheese-making':www.ncbe.ac.uk./NCBE/GM/FOOD.42such enzymes are now approved in a number of European countriesand in the United States.It is estimated that around 90 per cent of thehard cheese produced in Britain and 60 per cent of that produced inthe United States is made using chymosin from genetically modifiedmicrobes.Cheese made in this way is not required to be labelled differ-ently from other cheeses,though some producers and retailers havevoluntarily labelled it to indicate that it is made using componentsderived from genetically engineered bacteria or yeast.Baking and BrewingIn 1990,a special strain of bakers'yeast which had been geneticallyengineered to make bread dough rise more quickly was approved bythe regulatory authorities in the United Kingdom Ð the first suchapproval for a`live'genetically modified organism in food.18To date,this yeast has not been used by any food manufacturers.A good deal ofresearch has also been carried out on the genetic modification of brew-ing yeasts and a number of modified yeast strains have been developed.Though one modified yeast received approval for use in beer pro-duction in Britain in 1994,it has yet to be used by any brewer.Geneti-cally engineered yeasts designed for brewing were also developed inIreland,but have never been used commercially.MilkBovine somatropin (BST) is a hormone produced by the cow's pituitarygland at the base of the brain.19Though it has long been known thatinjecting cows with pituitary extracts could improve milk yield,thehormone could not be produced in sufficient quantities,or to an accept-able quality,for commercial use prior to the advent of genetic engineer-ing.In the 1980s,the gene expressing BST was isolated from cows andcloned in the E.coli bacterium using techniques similar to thosedeveloped for the production of insulin and other pharmaceuticals;18University of Reading.1998.`Genetically modified yeasts':www.ncbe.reading.ac.uk/NCBE/GMFOOD.19Nottingham,1996:op.cit.:27-33.43slightly different varieties of recombinant BST [rBST],or rBGH[recombinant Bovine Growth Hormone] as it is known in NorthAmerica,were developed by a number of companies.Administrationof the hormone is by injection every 14 or 28 days;the resultantincrease in milk yields is typically around 10-15 per cent.As the engine-ered version of the hormone is manufactured by bacteria using copiesof the cow's genes,the product administered to the cow is essentiallythe same as that made by the cow herself.Concerns have been expressed about the possible impact of rBST onhuman health.These centre on the fact that its use has been claimed tobe linked with the presence of higher levels of another hormone foundin milk,insulin gene factor or IGF-1.According to some experimentaland epidemiological studies,there is a possible association between IGF-1 and breast and prostate cancer.20The possible effects of rBST onanimal health have also aroused concern.According to a study by Can-adian veterinary scientists,its use is associated with significantly higherlevels of lameness,fertility problems,and mastitis among cattle.21Asmastitis is treated mainly with antibiotics,any rise in its incidence alsoraises fears about the spread of increased antibiotic resistance.There are marked divergences of view,however,about the risks ofrBST to human and animal health.In 1998,a joint expert committeeof the World Health Organization and the Food and AgricultureOrganization of the United Nations concluded that there were no foodsafety or health concerns related to rBST residues in products suchas milk or meat from treated animals.22Monsanto's recombinant BSThormone marketed under the Posilac brand name has been approvedfor use in the United States by the Food and Drug Administration[FDA] since 1993.A subsequent review by the FDA did not disclose20European Commission.1999.Scientific Committee on Veterinary Measures relating toPublic Health.Report on Public Health Aspects of the Use of Bovine Somatotropin.21Economist,3 July 1999:82.22Food and Agriculural Organization of the United Nations.5 March 1998.`Expert com-mittee:no danger to humans for milk and meat for BST-treated cows':www.fao.org/news/1998/980301.44evidence of any new or unexpected impacts on human or animalhealth.23The hormone is now applied to over 30 per cent of Americandairy cattle.24Marketing approval for rBST in the European Union was first soughtas far back as 1987.In 1991,the European Union decided that thereshould be a moratorium on its use until 1999.As well as the healthconcerns associated with the product,this decision was influenced bythe overproduction and declining consumption of milk in Europe.InAugust 1997,the World Trade Organization ruled that the EU couldno longer exclude meat and milk from cattle treated with rBST.InOctober 1999,the EU reaffirmed the ban on the use or marketing ofrBST in member states.The matter remains a subject of disputebetween the European Union and the United States.Earlier in 1999,Canada also decided to prohibit use of the hormone,primarily on ani-mal health grounds.IV The Commercialization of GM Crops andFoodsAs pharmaceutical and dairy products produced by techniques of gen-etic modification received regulatory approval and entered the market-place in the 1980s and early 1990s,plant biotechnology remained at thedevelopment and testing stage.25The first insertion of a foreign geneinto a plant took place in 1983 when a herbicide-resistance gene wasincorporated into a tobacco plant.The first experimental release of agenetically modified organism into the environment occurred in Cali-fornia in 1986 when approval was given for a field trial of strawberriessprayed with a bacterium engineered to lack an ice-nucleating proteinin order to confer greater resistance to frost.23Food and Drug Administration.1998.Report of Review of the Safety of RecombinantBovine Somatotropin:www.fda.gov/cvm/fda/infores/other/RBRPTFNL.24Monsanto,10 December 1999.Status Update:Posilac Bovine Somatotropin:www.monsanto.com/dairy/Press12131999.25Nottingham.1996,op.cit.:6-7.45Between 1986 and 1997,it is estimated that some 25,000 field trials of60 genetically modified crops were undertaken in 45 countries.26In theUS,maize,soybeans,and cotton have been the transgenic crops mostcommonly planted in trials;in Europe,the principal crops to feature infield trials have been oilseed rape,maize,sugar beet,potatoes,and tom-atoes.The predominant plant characteristic under test in these trials hasbeen tolerance to weed-killing herbicides.Other modified character-istics have included resistance to insects,increased storage or shelf-life,and resistance to viruses.The commercial cultivation of GM crops occurred first in China in theearly 1990s with the planting of virus-resistant tobacco and tomatoes.Inthe United States,the first genetically-modified fruit or vegetable to becleared for sale to consumers was the Flavr Savr tomato,a varietydeveloped by Calgene Inc.which stayed firm longer than conventionaltomatoes;the product received approval for sale to American consumersfrom the US Food and Drug Administration in May 1994.27Calgenescientists first identified the gene which makes tomatoes go soft duringripening Ða gene which expresses a pectinase enzyme that breaks downcell walls and converts solid plant tissue into softer tissue.They then pro-duced an antisense gene complementary to this target gene which inacti-vated its expression without affecting other aspects of the ripening process.The Flavr Savr tomato went on sale in late 1994 and by 1995 wasavailable in 3,000 stores in the western United States as well as in Can-ada and Mexico.28During the resultant expansion of commercial pro-duction,however,the tomato was withdrawn from production due tolow yields.Other varieties of tomato genetically modified for delayedripening or other characteristics are currently available on the US mar-ket or are in development.A second research group at the University26International Service for the Acquisition of Agri-Biotech Applications [ISAAA].1997.`Global status of transgenic crops in 1997':www.isaaa.org/frbrief5.27Center for Food Safety and Applied Nutrition,US Food and Drug Administration.September 1994.`First biotech tomato marketed':www.cfsan.fda.gov/~lrd/biotech.28University of Reading.1999.`Genetically modified tomatoes':www.ncbe.reading.ac.uk/NCBE/GMFOOD.46of Nottingham working in collaboration with Zeneca used a differentgene-silencing mechanism to produce a tomato with delayed ripeningfor use in processed food.This was used in tomato pureeÂsold inSainsbury and Safeway supermarkets in Britain from 1996 to 1999.The Growth in the Cultivation of GM CropsThe Food and Drug Administration's authorization of the sale of geneti-cally modified tomatoes in May 1994 signalled that the developmentand trial phase of the first generation of GM crops was coming to anend.By 1999,the US authorities had approved a further 40 or so appli-cations for the cultivation,sale,or importation of genetically modifiedcrops.29These included thirteen varieties of maize modified for herbi-cide tolerance or the production of proteins toxic to pests;four varietiesof herbicide-tolerant soybeans;and eleven varieties of tomato modifiedfor delayed ripening.Genetically modified crops have not only been widely approved for usein the United States,but have also been rapidly taken up by Americanfarmers.According to one estimate,the rate of their adoption has beenalmost twice that of previous new crop products such as hybrid maize.30Table 2 overleaf shows the extensive penetration of the American mar-ket achieved by genetically modified crops within the space of just threeto four years.The first year in which GM crops were cultivated on asignificant scale in the United States was 1996 when fewer than fourmillion acres were under cultivation.By 1999,this figure had risen to76 million acres with around 47 per cent of US soybean acreage,48per cent of cotton acreage,and 37 per cent of maize acreage given overto biotechnology crops.The rapid rise in the cultivation of geneticallymodified maize and soybeans is all the more significant because of theirwidespread use in processed foods.Maize is used in a wide range ofprocessed foods,including corn oil,cornflour,cornmeal,syrups,cereals,29USDA and Biotechnology:Questions and Answers:www.usda.gov/news/bioqa.30N.Kalaitzandonakes.1999.`A farm level perspective on agrobiotechnology:how much valueand for whom?'.AgBioForum,vol 2 (2),spring 1998:61-64.47